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Brukinsa(zanubrutinib)
Brukinsa (zanubrutinib) is a small molecule pharmaceutical. Zanubrutinib was first approved as Brukinsa on 2019-11-14. It is used to treat mantle-cell lymphoma in the USA. It has been approved in Europe to treat waldenstrom macroglobulinemia. It is known to target tyrosine-protein kinase BTK.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Brukinsa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Zanubrutinib
Tradename
Company
Number
Date
Products
BRUKINSABeigeneN-213217 RX2019-11-14
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
brukinsaNew Drug Application2020-08-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mantle-cell lymphomaD020522C83.1
Agency Specific
FDA
EMA
Expiration
Code
ZANUBRUTINIB, BRUKINSA, BEIGENE
2030-01-19ODE-274
2028-09-14ODE-370
2028-08-31ODE-371
2026-11-14ODE-276
2026-01-19I-817
2024-11-14NCE
2024-09-14I-874
2024-08-31I-871
Patent Expiration
Patent
Expires
Flag
FDA Information
Zanubrutinib, Brukinsa, Beigene
109271172037-08-15DS, DP
115913402037-08-15U-1745, U-2145, U-2537, U-2666, U-3063, U-3486
94471062034-04-22DS, DPU-1745, U-2145, U-2537, U-2666, U-3063, U-3486
105701392034-04-22U-1745, U-2145, U-2537, U-2666, U-3063, U-3486
111425282034-04-22DPU-1745, U-2145, U-2537, U-2666, U-3063, U-3486
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EL: Bruton's tyrosine kinase (btk) inhibitors
L01EL03: Zanubrutinib
HCPCS
No data
Clinical
Clinical Trials
93 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403C83.3314218
B-cell chronic lymphocytic leukemiaD015451C91.1210213
Mantle-cell lymphomaD020522C83.12629
Waldenstrom macroglobulinemiaD008258C88.03137
Non-hodgkin lymphomaD008228C85.91113
Hodgkin diseaseD006689C8111
Membranous glomerulonephritisD015433EFO_0004254N03.2111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3144
Follicular lymphomaD008224C82223
NeoplasmsD009369C80122
B-cell lymphomaD016393112
TherapeuticsD01381222
Lymphoid leukemiaD007945C9111
Lupus nephritisD008181EFO_000576111
Immunoglobulin g4-related diseaseD00007773311
Covid-19D000086382U07.111
Non-small-cell lung carcinomaD002289111
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients77
B-cell lymphoma marginal zoneD018442C88.411
Hepatic insufficiencyD04855011
LeukemiaD007938C9511
LymphomaD008223C85.911
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameZANUBRUTINIB
INNzanubrutinib
Description
Zanubrutinib, sold under the brand name Brukinsa, is an anticancer medication used for the treatment of mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic lymphocytic leukemia (CLL). Zanubrutinib is classified as a Bruton's tyrosine kinase (BTK) inhibitor. It is given by mouth.
Classification
Small molecule
Drug classtyrosine kinase inhibitors: tyrosine kinase inhibitors Bruton's (Btk) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C=CC(=O)N1CCC([C@@H]2CCNc3c(C(N)=O)c(-c4ccc(Oc5ccccc5)cc4)nn32)CC1
Identifiers
PDB
CAS-ID1691249-45-2
RxCUI
ChEMBL IDCHEMBL3936761
ChEBI ID
PubChem CID135565884
DrugBankDB15035
UNII IDAG9MHG098Z (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
BTK
BTK
Organism
Homo sapiens
Gene name
BTK
Gene synonyms
AGMX1, ATK, BPK
NCBI Gene ID
Protein name
tyrosine-protein kinase BTK
Protein synonyms
agammaglobulinaemia tyrosine kinase, Agammaglobulinemia tyrosine kinase, ATK, B-cell progenitor kinase, BPK, Bruton agammaglobulinemia tyrosine kinase, Bruton tyrosine kinase, Bruton's tyrosine kinase, dominant-negative kinase-deficient Brutons tyrosine kinase
Uniprot ID
Mouse ortholog
Btk (12229)
tyrosine-protein kinase BTK (Q61365)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 859 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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5,869 adverse events reported
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